Acrivon Therapeutics, Inc.
For the period ended Dec 31, 2025. Filed Mar 19, 2026.
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FY2025 · Filed Mar 19, 2026
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Notes to the Consolidated Financial Statements
- Nature of the Business
Acrivon Therapeutics, Inc. (the “Company”) is a clinical-stage biopharmaceutical company discovering and developing precision medicines utilizing its proprietary Generative Phosphoproteomics Acrivon Predictive Precision Proteomics (“AP3”) platform designed to interpret and quantify compound-specific, drug-regulated pathway activity levels inside the intact cell in an unbiased manner, yielding terabytes of proprietary data and delivering rapid, actionable insights. The Company is currently focused on oncology and advancing its pipeline of preclinical and clinical-stage small molecule inhibitors. ACR-368 (also known as prexasertib), which is a selective small molecule inhibitor targeting CHK1 and CHK2, is in a potentially registrational Phase 2 trial focusing on endometrial cancer (“EC”). ACR-2316 is a novel, potent and selective inhibitor of WEE1 and PKMYT1 that is currently being advanced in Phase 1 studies for selected solid tumor types predicted sensitive by AP3. In addition, the Company is advancing ACR-6840, an internally discovered development candidate targeting CDK11 with planned IND filing in the fourth quarter 2026.
The Company has received Fast Track designation from the U.S. Food and Drug Administration (“FDA”) for the investigation of ACR-368 as monotherapy based on OncoSignature-predicted sensitivity in patients with EC. The FDA has also granted Breakthrough Device designation for the ACR-368 OncoSignature assay for the identification of EC patients who may benefit from ACR-368 treatment. EC had not been previously studied in prior ACR-368 trials sponsored by Eli Lilly and Company (“Lilly”). Using AP3 for indication screening, this tumor type was predicted to be particularly sensitive to ACR-368 prior to the current ongoing Phase 2 study.
In March 2025, the Company reported positive clinical data from the ongoing registrational intent, multicenter Phase 2 trial of ACR-368 in patients with recurrent EC who had progressed after prior platinum-based chemotherapy and anti-PD-1 therapy. This study, where the OncoSignature is used for prospective response prediction to ACR-368 monotherapy, reported a 35% confirmed overall response rate and 80% tumor shrinkage in OncoSignature-positive patients.
The Company’s second clinical-stage asset, ACR-2316, is a novel, selective WEE1/PKMYT1 inhibitor designed using AP3 for superior single-agent activity through strong activation of not only CDK1 and CDK2 but also of PLK1 to drive pro-apoptotic cell death, as observed in preclinical studies against benchmark inhibitors. In October 2024, only 15 months after initial lead identification, the Company announced that the first patient had been dosed in the Phase 1 clinical trial that was designed to assess the safety and tolerability of ACR-2316, determine the recommended Phase 2 monotherapy dose, and evaluate preliminary anti-tumor activity. In March 2025, the Company reported significant drug target engagement from patient peripheral blood mononuclear cells in the ongoing trial at Dose Level (“DL”) 1 using the Company’s proprietary clinical AP3-based mass spectrometry assay. In August the Company reported initial clinical activity with tumor shrinkage observed across several solid tumor types predicted to be sensitive by AP3, including a confirmed partial response at DL3, which is below the projected recommended phase 2 dose.
The Company was incorporated in March 2018 under the laws of the state of Delaware, and its principal offices are in Watertown, Massachusetts. Also in March 2018, the Company formed Acrivon AB, a wholly-owned subsidiary of the Company, established in Lund, Sweden. In December 2021, the Company formed Acrivon Securities Corporation, a wholly-owned subsidiary, established in Massachusetts.
Liquidity
As an emerging growth entity, the Company has devoted substantially all of its resources since inception to organizing and staffing the Company, business planning, raising capital, establishing its intellectual property portfolio, acquiring and discovering drug candidates, research and development activities for the Company’s in-licensed lead candidate ACR-368 and for the Company’s internally discovered clinical-stage asset, ACR-2316, and other compounds, establishing arrangements with third parties for the manufacture of its drug candidates and component materials, and providing general and administrative support for these operations. As a result, the Company has incurred significant operating losses and negative cash flows from operations since its inception and anticipates such losses and negative cash flows will continue for the foreseeable future.
The Company has incurred recurring losses since its inception, including net losses of $77.9 million and $80.6 million for the years ended December 31, 2025, and 2024, respectively, and negative cash flows from operations. As of December 31, 2025 and 2024, the Company had an accumulated deficit of $274.9 million and $197.0 million, respectively. To date the Company has not generated any revenues and expects to continue generating operating losses for the foreseeable future as it continues to expand its research and development efforts.
Since its inception, the Company has funded its operations primarily with proceeds from the sales of shares of its convertible preferred stock, the issuance of convertible notes, and an initial public offering (“IPO”) and concurrent private placement. Upon the closing of the Company’s IPO on November 17, 2022, only common stock remains issued and outstanding. On April 8, 2024, the Company entered into a Private Investment in Public Equity (“PIPE”) securities purchase agreement (the “PIPE Purchase Agreement”) for a private placement with certain institutional and accredited investors (the “April 2024 Private Placement”). Pursuant to the PIPE Purchase Agreement, the Company agreed to issue and sell to the PIPE investors an aggregate of (i)8,235,000 shares of the Company’s common stock at a purchase price of $8.50 per share, and (ii) pre-funded warrants (“Pre-Funded Warrants”) to purchase up to an aggregate of 7,060,000 shares of the Company’s common stock at a purchase price of $8.499 per Pre-Funded Warrant, which represents the per share purchase price of the Company’s common stock less the $0.001 per share exercise price for each Pre-Funded Warrant. As of December 31, 2025, the Pre-Funded Warrants are exercisable at any time after the date of issuance and do not expire. The April 2024 Private Placement closed on April 11, 2024, for aggregate net proceeds of $123.8 million, after deducting fees and expenses of $6.2 million. The April 2024 Private Placement is further described in Note 8.
The Company expects that its existing cash, cash equivalents and investments of $118.6 million as of December 31, 2025, will be sufficient to fund its operating expenses and capital expenditure requirements for at least 12 months from the date these consolidated financial statements were issued.
The Company will need additional funding to support its planned operating activities. There can be no assurances, however, that the current operating plan will be achieved or that additional funding will be available on terms acceptable to the Company, or at all, considering the current interest rate environment. If the Company is unable to obtain sufficient funding, it could be required to delay its development efforts, limit activities, and reduce research and development costs, which could adversely affect its business prospects.
- Summary of Significant Accounting Policies
Basis of Presentation and Consolidation
The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and include the operations of Acrivon Therapeutics, Inc. and its wholly-owned subsidiaries. All intercompany accounts, transactions and balances have been eliminated in consolidation.
Use of Estimates
The preparation of the Company’s consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, the accrual of research and development expenses and the valuation of stock-based awards. The Company bases its estimates on historical experience when available, known trends and other market specific data, or other relevant factors that it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates when there are changes in circumstances, facts and experience. Changes in estimates and assumptions are reflected in reported results in the period in which they become known. Actual results could differ from those estimates.
Segment Information
The Company hasone reportable segment focused on the research and development of precision oncology therapies and manages its operations on a consolidated basis for the purpose of allocating resources. The Company’s chief operating decision maker is itschief executive officer, who reviews financial information presented on a consolidated basis for purposes of making operating decisions, assessing financial performance, and allocating resources. As of December 31, 2025, $5.1 million and $2.3 million of the Company’s long-lived assets are held in the United States and in Sweden, respectively. As of December 31, 2024, $4.9 million and $3.1 million of the Company’s long-lived assets are held in the United States and in Sweden, respectively.
Cash and Cash Equivalents
The Company considers all highly liquid investments purchased with original maturities of 90 days or less at acquisition to be cash equivalents. Cash and cash equivalents include standard checking accounts and amounts held in money market funds. Money market funds include amounts held in a cash sweep account. Periodically, the Company maintains deposits in accredited financial institutions in excess of federally insured limits.
Restricted Cash
Cash accounts with any type of restriction are classified as restricted cash. The Company has restricted cash deposits with a bank, which serve as collateral for a letter of credit issued to the landlord of the Company’s leased facility for a security deposit. The Company classified this amount as restricted cash in the accompanying consolidated balance sheets within non-current assets based on the release date of restrictions.
Deferred Offering Costs
The Company capitalizes certain legal, professional accounting and other third-party fees that are directly associated with in-process equity financings as deferred offering costs in the accompanying consolidated balance sheets within other assets until such financings are consummated. After consummation of an equity financing, these costs are recorded as a reduction of the proceeds from the offering in stockholders’ equity as a reduction of additional paid-in capital generated as a result of the offering. Should the Company choose to not initiate such financing, the deferred offering costs would be immediately expensed as operating expenses.
Deferred offering costs associated with the ATM Program are reclassified to additional paid-in-capital on a pro-rata basis when the Company completes offerings under the ATM Program. Any remaining deferred offering costs will be expensed to the consolidated statements of operations and comprehensive loss should the planned offering be abandoned. As of December 31, 2025, $0.5 million of such deferred offering costs are capitalized.
Concentration of Credit Risk and Significant Suppliers
Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash, cash equivalents and investments. The Company has not experienced any credit losses on its cash, cash equivalents, or investments. The Company maintains its cash, cash equivalents and investments, which at times exceed insurance limits, at major financial institutions. The Company has not experienced any losses in such accounts and management believes that such funds are not exposed to any significant credit or concentration risk. However, the Company may face exposure, including constraint on liquidity and access to capital, if there is failure by these or other financial institutions.
The Company is dependent on third-party contract research organizations (“CROs”) and contract manufacturing organizations to supply certain intellectual property and services for research activities in its drug candidates. In particular, the Company relies and expects to continue to rely on a small number of these organizations to supply it with its requirements for key raw materials related to these programs. These drug candidates could be adversely affected by a significant interruption in the supply of key raw materials. Additionally, the Company relies on a single companion diagnostic collaborator to perform ACR-368 OncoSignature tests in the Company’s clinical trials (see Note 13).
Comprehensive Loss
Comprehensive loss is defined as a change in equity of a business enterprise during a period resulting from transactions from non-owner sources. Comprehensive loss includes net loss and certain changes in stockholders' equity that are excluded from net loss. The Company had a net change in available-for-sale securities during the years ended December 31, 2025 and 2024, which met the criteria as other comprehensive (loss) income and, therefore, the Company’s comprehensive loss includes unrealized loss and unrealized gain on those available-for-sale securities during the years ended December 31, 2025 and 2024, respectively.
Investments
The Company classifies all investments with an original maturity of greater than three months and less than one year upon purchase as short-term investments. The Company classifies all investments with an original maturity of greater than one year upon purchase as long-term investments. The Company's investments are classified as available-for-sale securities when investments are available to fund operations, even if the Company intends to hold the investments to maturity. As of December 31, 2025 and 2024, all investments have been classified as available-for-sale securities. Available-for-sale securities are recorded at fair value based upon market prices at period end, with the unrealized gains and losses reported in other comprehensive income (loss). The amortized cost of debt securities in this category is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization is included in interest income in the consolidated statements of operations and comprehensive loss. Realized gains and losses and declines in value due to credit-related factors on available-for-sale securities are included in other expense, net in the consolidated statements of operations and comprehensive loss. The cost of securities sold is based on the specific identification method. Interest on securities classified as available-for-sale is included in interest income in the consolidated statements of operations and comprehensive loss.
Ateach balance sheet date, the Company assesses available-for-sale debt securities in an unrealized loss position to determine whether the unrealized loss or any potential credit losses should be recognized in the consolidated statements of operations and comprehensive loss. The Company evaluates whether it intends to sell, or it is more likely than not that it will be required to sell, the security before recovery of its amortized cost basis. The Company also evaluates whether the decline in fair value has resulted from credit losses or other factors. In making this assessment, the Company considers the severity of the impairment, any changes in interest rates, changes to the underlying credit ratings and forecasted recovery, among other factors. The credit-related portion of unrealized losses, and any subsequent improvements, are recorded in other expense, net. There have been no impairment or credit losses recognized during any of the periods presented.
Fair Value Measurements
Accounting Standards Codification (“ASC”) Topic 820, Fair Value Measurement (“ASC 820”), establishes a fair value hierarchy for instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and the Company’s own assumptions (unobservable inputs). Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the inputs that market participants would use in pricing the asset or liability and are developed based on the best information available in the circumstances.
ASC 820 identifies fair value as the exchange price, or exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As a basis for considering market participant assumptions in fair value measurements, ASC 820 establishes a three-tier fair value hierarchy that distinguishes among the following:
Level 1—Quoted prices in active markets for identical assets or liabilities.
Level 2—Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data.
Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.
To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement.
Property and Equipment, net
Property and equipment are stated at cost, less accumulated depreciation. Costs for capital assets not yet placed in service are capitalized as construction in progress and depreciated once placed in service. Costs of major additions and betterments are capitalized. Maintenance and repairs which do not improve or extend the life of the respective assets are charged to expense as incurred. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets, which range from three to seven years. Leasehold improvements are amortized over the shorter of the lease term or the estimated useful life of the related asset. The Company's leasehold improvements as of December 31, 2025 and 2024 were immaterial. When an item is sold or retired, the costs and related accumulated depreciation are eliminated, and the resulting gain or loss, if any, is credited or charged to the consolidated statements of operations and comprehensive loss. Property and equipment to be disposed of are carried at fair value less costs to sell. The estimated useful lives of the Company’s property and equipment are as follows:
| Estimated Useful Life (in Years) | |
| Laboratory equipment and computer equipment | 3-5 years |
|---|---|
| Furniture and fixtures | 5-7 years |
| Leasehold improvements | Lesser of asset useful life or lease term |
Impairment of Long-Lived Assets
The Company recognizes an impairment loss in the consolidated statements of operations and comprehensive loss only if the carrying amount of a long-lived asset is not recoverable based on its undiscounted future cash flows and in such case, measures an impairment loss as the difference between the carrying amount and the fair value of the asset.
The Company tests long-lived assets to be held and used, including property and equipment and operating lease right-of-use (“ROU”) assets, for impairment whenever events or changes in circumstances indicate that the carrying amount of assets or asset groups maynot be fully recoverable. Determination of recoverability is based on an estimate of undiscounted future cash flows resulting from the use of the asset and its eventual disposition. In the event that such cash flows are not expected to be sufficient to recover the carrying amount of the assets, the assets are written down to their fair values. The Company hasnot recognized any impairment losses during the years ended December 31, 2025 and 2024.
Research and development costs include (i) employee-related expenses, including salaries, benefits, and stock-based compensation expense; (ii) external research and development expenses incurred under arrangements with third parties, such as CRO agreements and consultants; (iii) costs associated with preclinical activities; and (iv) lab supplies, lab expenses and an allocation of rent, depreciation, and infrastructure. Costs incurred in connection with research and development activities are expensed as incurred.
The Company enters into various consulting, research, and other agreements with commercial firms, researchers, universities and other external parties for the provision of goods and services. Such arrangements are generally cancelable upon reasonable notice and payment of costs incurred.
Costs are considered incurred based on an evaluation of the progress to completion of specific tasks under each contract using information and data provided by the Company’s clinical sites and vendors. These costs consist of direct and indirect costs associated with specific projects, as well as fees paid to various entities that perform certain research on behalf of the Company. Depending upon the timing of payments to the service providers, the Company recognizes prepaid expenses or accrued expenses related to these costs. These accrued or prepaid expenses are based on management’s estimates of the work performed under service agreements, milestones achieved, and experience with similar contracts. Milestone payments under license agreements are accrued, with a corresponding expense being recognized, in the period in which the milestone is determined to be probable of achievement and the related amount is reasonably estimable. The Company monitors each of these factors and adjusts estimates accordingly. The Company has not experienced any material differences between accrued costs and actual costs incurred since its inception.
Patent Costs
All patent-related costs incurred in connection with filing and prosecuting patent applications such as direct application fees, and legal and consulting expenses are expensed as incurred due to the uncertainty about the recovery of the expenditure. Patent-related costs are classified as general and administrative expenses within the Company’s consolidated statements of operations and comprehensive loss.
Foreign Currency Transactions
The functional currency for the Company’s wholly-owned foreign subsidiary, Acrivon AB, is the United States dollar. All foreign currency transaction gains and losses are recognized in the consolidated statements of operations and comprehensive loss through other expense, net. The Company recognized a net foreign currency transaction gain of $0.2 million during the year ended December 31, 2025, and a net foreign currency transaction loss of $0.1 million during the year ended December 31, 2024, which are primarily related to unrealized and realized foreign currency gains and losses as a result of transactions entered into by Acrivon AB in currencies other than the United States dollar.
Leases
Effective on January 1, 2021, the Company accounts for leases in accordance with Accounting Standards Update (“ASU”) No. 2016-02, Leases, as subsequently amended (collectively, “ASC 842”). In accordance with ASC 842, the Company determines whether an arrangement is or contains a lease at inception. A contract is or contains a lease if the contract conveys the right to control the use of an identified asset for a period of time in exchange for consideration. The Company classifies leases at the lease commencement date, when control of the underlying asset is transferred from the lessor to the lessee, as operating or finance leases and records a ROU asset and a lease liability on the consolidated balance sheets for all leases with an initial lease term of greater than 12 months. The Company has elected to not recognize leases with a lease term of 12 months or less, but payments are recognized as expense on a straight-line basis over the lease term.
The Company enters into contracts that contain both lease and non-lease components. Non-lease components may include maintenance, utilities, and other operating costs. For leases of real estate, the Company combines the lease and associated non-lease components in its lease arrangements as a single lease component. Variable costs, such as utilities or maintenance costs, are not included in the measurement of right-of-use assets and lease liabilities, but rather are expensed when the event determining the amount of variable consideration to be paid occurs.
Finance and operating lease assets and liabilities are recognized at the lease commencement date based on the present value of the lease payments over the lease term using the discount rate implicit in the lease if readily determinable. If the rate implicit is not readily determinable, the Company utilizes its incremental borrowing rate, which reflects the fixed rate at which the Company could borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. ROU assets are further adjusted for initial direct costs, prepaid rent, or incentives received. Operating lease payments are expensed using the straight-line method as an operating expense over the lease term. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Finance lease assets are amortized to depreciation expense using the straight-line method over the shorter of the useful life of the related asset or the lease term. Finance lease payments are bifurcated into (i) a portion that is recorded as interest expense using the effective interest method and (ii) a portion that reduces the finance liability associated with the lease.
In addition, the Company examines other contracts with suppliers, vendors and outside parties to identify whether such contracts contain an embedded lease and, as applicable, records such embedded leases in accordance with ASC 842.
Stock-Based Compensation
The Company accounts for all stock-based payment awards granted to employees and non-employees as stock-based compensation expense at fair value, based on the date of the grant, and recognizes compensation expense for those awards over the requisite service period, which is generally the vesting period of the respective award. The Company’s stock-based payments include stock options and grants of common stock. The measurement date for employee awards is the date of grant, and stock-based compensation costs are recognized as expense over the employees’ requisite service period, which is the vesting period, on a straight-line basis. The Company adopted ASU No. 2018-07, Compensation—Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting(“ASU No. 2018-07”) prior to the issuance of any stock option grants. The measurement date for non-employee awards is the date of grant, and stock-based compensation costs for non-employees are recognized as expense over the vesting period on a straight-line basis. The Company accounts for forfeitures as they occur. Stock-based compensation expense is classified in the accompanying consolidated statements of operations and comprehensive loss in the same manner in which the award recipient’s payroll costs are classified or in which the award recipients service payments are classified.
The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model, which requires inputs based on certain subjective assumptions. The Company has historically been a private company and lacks company-specific historical and implied volatility information. The Company estimates its expected stock volatility based on the historical volatility of a publicly traded set of representative companies and expects to continue to do so until such time as it has adequate historical data regarding the volatility of its own traded stock price. The expected term of the Company’s stock options has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that the Company has never paid cash dividends on common stock and does not expect to pay any cash dividends in the foreseeable future. The fair value of the Company's common stock is determined based on the quoted market price of common stock.
Pre-Funded Warrants
Warrants are accounted for based on the specific terms of the warrant agreements. The Company's Pre-Funded Warrants are indexed to the Company's common stock and meet the criteria to be classified as equity. Proceeds from the issuance of Pre-Funded Warrants are recorded within additional paid-in capital and are not subject to remeasurement. Refer to Note 8 and Note 11 for further information regarding Pre-Funded Warrants issued by the Company.
Net Loss per Share
Basic net loss per share is computed by dividing net loss by the weighted-average number of common shares outstanding during the period. Diluted net loss per share is computed using the weighted-average number of common shares outstanding during the period and, if dilutive, the weighted-average number of potential shares of common stock. Net loss per share attributable to common stockholders is calculated using the two-class method, which is an earnings allocation formula that determines net loss per share for the holders of the Company’s common shares and participating securities. Net loss attributable to common stockholders is allocated to each share on an as-converted basis as if all of the earnings for the period had been distributed. The participating securities did not include a contractual obligation to share in losses of the Company and are not included in the calculation of net loss per share in the periods in which a net loss is recorded.
Diluted net loss per share is computed using the more dilutive of (a) the two-class method or (b) the if-converted method. The Company allocates earnings first to preferred stockholders based on dividend rights and then to common and preferred stockholders based on ownership interests. The weighted-average number of common shares included in the computation of diluted net loss per share gives effect to all potentially dilutive common equivalent shares, including outstanding stock options and preferred stock.
Issued and unexercised Pre-Funded Warrants are classified as a component of permanent equity in the Company's consolidated balance sheet as they are freestanding financial instruments that are immediately exercisable, do not embody an obligation for the Company to repurchase its own shares and permit the holders to receive a fixed number of shares of common stock upon exercise. All shares underlying Pre-Funded Warrants are included in the weighted-average number of shares of common stock used to calculate basic and diluted net loss per common share because the shares may be issued for little or no consideration, are fully vested and are exercisable after the original issuance date of the Pre-Funded Warrants.
Common stock equivalent shares are excluded from the computation of diluted net loss per share if their effect is antidilutive. In periods in which the Company reports a net loss attributable to common stockholders, diluted net loss per share attributable to common stockholders is the same as basic net loss per share attributable to common stockholders since dilutive common shares are not assumed to have been issued if their effect is antidilutive. The Company reported a net loss attributable to common stockholders for the years ended December 31, 2025 and 2024.
Income Taxes
The Company accounts for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the consolidated financial statements or the Company’s tax returns. Under this method, deferred tax assets and liabilities are determined based on the differences between the consolidated financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes. The Company assesses the likelihood that its deferred tax assets will be recovered from future taxable income and, to the extent it believes, based upon the weight of available evidence, that it is more likely than not that all or a portion of the deferred tax assets will not be realized, a valuation allowance is established.
The Company accounts for uncertain tax positions recognized in the consolidated financial statements by prescribing a “more likely than not” threshold for financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. There are no unrecognized tax benefits included in the Company’s consolidated balance sheets as of December 31, 2025 and 2024. The Company’s policy is to recognize interest and penalties related to income tax matters in income tax expense. The Company has not recognized interest or penalties in its consolidated statements of operations and comprehensive loss since inception.
Recently Adopted Accounting Pronouncements
ASU 2023-09, Income Taxes (Topic 740)
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which includes amendments that further enhance income tax disclosure, primarily through standardization and disaggregation of rate reconciliation categories and income taxes paid by jurisdiction. Thenew standard is effective for annual periods beginning after December 15, 2024.
Recently Issued Accounting Pronouncements Not Yet Adopted
ASU 2023-06, Disclosure Improvements
In October 2023, the FASB issued ASU 2023-06, Disclosure Improvements: Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative. The amendments clarify or improve disclosure and presentation requirements on various disclosure areas, including the statement of cash flows, earnings per share, debt, equity, and derivatives. The amendments will align the requirements in the FASB ASC with the SEC’s regulations. The amendments in this ASU will be effective on the date the related disclosures are removed from Regulation S-X or Regulation S-K by the SEC, and will not be effective if the SEC has not removed the applicable disclosure requirement by June 30, 2027. Early adoption is prohibited. As the Company is currently subject to these SEC requirements, ASU 2023-06 is not expected to have a significant impact on the Company.
ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40)
In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, which requires entities to disclose additional information about specific expense categories in the notes to the financial statements. The ASU is effective for annual periods beginning after December 15, 2026 and for interim periods within fiscal years beginning after December 15, 2027. Early adoption is permitted. ASU 2024-03 may be applied retrospectively or prospectively. The Company is currently evaluating the effect of this update on its consolidated financial statements and related disclosures.
- Investments
The following tables summarize the amortized cost and estimated fair value of the Company's available-for-sale investments as of December 31, 2025 and 2024 (in thousands):
| Amortized Cost | Gross UnrealizedGains | Fair Value | |
|---|---|---|---|
| Short-term investments: | |||
| U.S. Treasury securities | $66,991 | $101 | $67,092 |
| U.S. government-sponsored enterprise securities | 9,981 | 10 | 9,991 |
| $76,972 | $111 | $77,083 | |
| Amortized Cost | Gross UnrealizedGains | Fair Value | |
|---|---|---|---|
| Short-term investments: | |||
| U.S. Treasury securities | $129,294 | $436 | $129,730 |
| U.S. government-sponsored enterprise securities | 9,926 | 6 | 9,932 |
| Long-term investments: | |||
| U.S. Treasury securities | 5,084 | 5 | 5,089 |
| $144,304 | $447 | $144,751 | |
Certain short-term debt securities with original maturities of less than 90 days are included in cash and cash equivalents on the consolidated balance sheets and are not included in the tables above. As of December 31, 2025 and 2024, all short-term investments had contractual maturities withinone year. As of December 31, 2024, all long-term investments had contractual maturities betweenone totwo years.
There wereno available-for-sale securities held by the Company in an unrealized loss position as of December 31, 2025. As such, the Company does not consider these investments to be impaired and there areno allowances for credit losses as of December 31, 2025.
- Fair Value Measurement
The following tables present information about the Company’s financial assets measured at fair value on a recurring basis and indicate the level of the fair value hierarchy to determine such fair value as of December 31, 2025 and 2024 (in thousands):
| Fair Value Measurements at December 31, 2025: | ||||
|---|---|---|---|---|
| Total | Level 1 | Level 2 | Level 3 | |
| Cash equivalents: | ||||
| Money market funds | $39,719 | $39,719 | $— | $— |
| Short-term investments: | ||||
| U.S. Treasury securities | 67,092 | — | 67,092 | — |
| U.S. government-sponsored enterprise securities | 9,991 | — | 9,991 | — |
| Total assets | $116,802 | $39,719 | $77,083 | $— |
| Fair Value Measurements at December 31, 2024: | ||||
|---|---|---|---|---|
| Total | Level 1 | Level 2 | Level 3 | |
| Cash equivalents: | ||||
| Money market funds | $38,442 | $38,442 | $— | $— |
| Short-term investments: | ||||
| U.S. Treasury securities | 129,730 | 129,730 | — | — |
| U.S. government-sponsored enterprise securities | 9,932 | — | 9,932 | — |
| Long-term investments: | ||||
| U.S. Treasury securities | 5,089 | 5,089 | — | — |
| Total assets | $183,193 | $173,261 | $9,932 | $— |
The Company classifies its money market funds and on-the-run U.S. Treasury securities as Level 1 assets under the fair value hierarchy as these assets have been valued using quoted market prices in active markets without any valuation adjustment. The Company classifies its off-the-run U.S. Treasury securities and U.S. government-sponsored enterprise securities as Level 2 assets under the fair value hierarchy as these assets have been valued using information obtained through a third-party pricing service as of the balance sheet date, using observable market inputs that may include trade information, broker or dealer quotes, bids, offers, or a combination of these data sources.
During the years ended December 31, 2025 and 2024, there wereno transfers between levels. The Company uses the carrying amounts of its restricted cash, prepaid expenses and other current assets, accounts payable and accrued expenses and other current liabilities to approximate their fair values due to the short-term nature of these amounts.
- Property and Equipment, net
Property and equipment, net consisted of the following as of December 31, 2025 and 2024 (in thousands):
| December 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Laboratory and computer equipment | $7,091 | $6,175 |
| Construction in progress | 916 | 58 |
| Furniture and fixtures | 200 | 200 |
| Total property and equipment | 8,207 | 6,433 |
| Less: accumulated depreciation | (3,318) | (1,962) |
| Total property and equipment, net | $4,889 | $4,471 |
Depreciation expense related to property and equipment for the years ended December 31, 2025 and 2024 was $1.4 million and $1.0 million, respectively.
- Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following as of December 31, 2025 and 2024 (in thousands):
| December 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Accrued research and development expenses | $5,960 | $9,246 |
| Accrued compensation and benefits | 5,558 | 5,456 |
| Accrued legal, accounting and other professional fees | 375 | 458 |
| Accrued other | 179 | 239 |
| Accrued offering costs | 143 | — |
| Total accrued expenses and other current liabilities | $12,215 | $15,399 |
- Leases
In December 2020, the Company entered into an operating lease agreement for laboratory and office space located at 480 Arsenal Way, Watertown, Massachusetts (the “Arsenal Way Lease”). The lease commenced in April 2021, with a term of seven years and an option toextend the term for an additional five years at then-market rental rates. The Company delivered a letter of credit of $0.3 million to the landlord, which was subsequently reduced to $0.2 million in August 2024 in accordance with the lease, which is included in restricted cash in the accompanying consolidated balance sheets. Under the terms of the lease, the base rent is $1.0 million, subject to a 3% annual rent increase, plus an allocation of operating expenses and taxes.
In August 2023, the Company entered into an operating lease agreement, denominated in Swedish Krona, for office and laboratory space located in Lund, Sweden. The term of the lease commenced in December 2023. The lease has an initial term ofthree yearsand will automatically renew for an additional term ofthree years unless the Company provides written notice of termination nine months prior to the termination date.
In July 2024, the Company entered into an operating lease agreement, denominated in Swedish Krona, for additional office and laboratory space adjacent to its existing leased space located in Lund, Sweden. The term of the lease commenced in September 2024. The lease has an initial term ofthree years and will automatically renew for an additional term ofthree years unless the Company provides written notice of termination nine months prior to the termination date.
The following table summarizes the presentation of the Company’s operating leases on its consolidated balance sheets as of December 31, 2025 and 2024 (in thousands):
| Leases | Balance sheet classification | December 31, 2025 | December 31, 2024 |
|---|---|---|---|
| Assets: | |||
| Operating lease assets | Operating lease right-of-use assets | $2,527 | $3,554 |
| Total lease assets | $2,527 | $3,554 | |
| Liabilities: | |||
| Current: | |||
| Operating lease liabilities | Operating lease liability, current | $1,172 | $1,057 |
| Noncurrent: | |||
| Operating lease liabilities | Operating lease liability, non-current | 1,537 | 2,588 |
| Total lease liabilities | $2,709 | $3,645 | |
The components of lease cost under ASC 842 included within research and development expenses and general and administrative expenses in the Company’s consolidated statements of operations and comprehensive loss for the years ended December 31, 2025 and 2024 were as follows (in thousands):
| For the Year Ended December 31, | ||
|---|---|---|
| Lease cost | 2025 | 2024 |
| Operating lease cost | $1,293 | $1,276 |
| Variable lease cost | 608 | 645 |
| Total lease cost | $1,901 | $1,921 |
As of December 31, 2025 and 2024, the weighted-average remaining lease term for operating leases was 2.3 years and 3.2 years, respectively, and the weighted-average discount rate was 8.17% and 8.26%, respectively. Cash paid for amounts included in the measurement of lease liabilities was $1.3 million and $1.4 million for the years ended December 31, 2025 and 2024, respectively.
Future minimum annual lease commitments under the Company’s non-cancelable operating leases as of December 31, 2025 were as follows (in thousands):
| Year ended December 31, | Amount |
|---|---|
| 2026 | $1,341 |
| 2027 | 1,210 |
| 2028 | 404 |
| Total lease payments | 2,955 |
| Less: interest | (246) |
| Present value of operating lease liabilities | $2,709 |
- Stockholders' Equity
In October 2022, the Board of Directors (“Board”) approved the amended and restated certificate of incorporation, which was filed upon the closing of the IPO and which authorized the Company to issue up to 10,000,000 shares of preferred stock, with a par value of $0.001. There areno shares of preferred stock issued or outstanding as of December 31, 2025.
As of December 31, 2025 and 2024, the Company’s Amended and Restated Certificate of Incorporation authorized the Company to issue 500,000,000 shares of common stock with a par value of $0.001. The voting, dividend and liquidation rights of the holders of the Company’s common stock are subject to and qualified by the rights, powers and preferences of the holders of preferred stock.
The holders of the common stock are entitled to one vote for each share of common stock held at all meetings of stockholders (and written actions in lieu of meetings), and there are not any cumulative voting rights. The number of authorized shares of common stock may be increased or decreased by the affirmative vote of the holders of shares of capital stock of the Company; however, the issuance of common stock may be subject to the vote of the holders of one or more series of preferred stock that may be required by terms of the Amended and Restated Certificate of Incorporation.
PIPE Securities Purchase Agreement
On April 8, 2024, the Company entered into the PIPE Purchase Agreement for a private placement with certain institutional and accredited investors. Pursuant to the PIPE Purchase Agreement, the Company agreed to issue and sell to the PIPE investors an aggregate of (i)8,235,000 shares of the Company’s common stock at a purchase price of $8.50 per share, and (ii)Pre-Funded Warrantsto purchase up to an aggregate of 7,060,000 shares of the Company’s common stock at a purchase price of $8.499 per Pre-Funded Warrant, which represents the per share purchase price of the Company’s common stock less the $0.001 per share exercise price for each Pre-Funded Warrant. As of December 31, 2025, the Pre-Funded Warrants are exercisable at any time after the date of issuance and do not expire.
The holders of Pre-Funded Warrants may not exercise a Pre-Funded Warrant if the holder, together with its affiliates, would beneficially own more than 4.99% of the number of shares of common stock outstanding immediately after giving effect to such exercise. The holders of Pre-Funded Warrants may increase or decrease such percentage by providing at least 61 days’ prior notice to the Company, but not in excess of 19.99% in the case of an increase. The Pre-Funded Warrants are indexed to the Company's common stock and were classified as a component of permanent equity in the Company's consolidated balance sheet as they are freestanding financial instruments that are immediately exercisable, do not embody an obligation for the Company to repurchase its own shares and permit the holders to receive a fixed number of shares of common stock upon exercise. The April 2024 Private Placement closed on April 11, 2024, for aggregate net proceeds of $123.8 million, after deducting fees and expenses of $6.2 million. As of December 31, 2025, no Pre-Funded Warrants were exercised.
Common Stock
As of December 31, 2025 and 2024, the Company had reserved the following shares of common stock for the potential exercise of stock options, potential exercise of Pre-Funded Warrants, vesting of restricted stock units (“RSUs”), as well as the remaining shares available for issuance under the 2022 Equity Incentive Plan (the “2022 Plan”), the 2022 Employee Stock Purchase Plan (the “2022 ESPP”), and the Amended and Restated 2023 Inducement Plan (the “Inducement Plan”):
| December 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Options to purchase common stock | 6,176,141 | 4,485,546 |
| Pre-funded warrants to purchase common stock | 7,060,000 | 7,060,000 |
| Unvested restricted stock units | 222,252 | 975,550 |
| Remaining shares reserved for future issuance | 3,420,334 | 2,401,347 |
| Total | 16,878,727 | 14,922,443 |
- Stock-Based Compensation
Equity Incentive Plans
In October 2022, the Board adopted, and in November 2022 its stockholders approved, the 2022 Plan, which became effective immediately prior to and contingent upon the execution of the underwriting agreement related to the Company’s IPO. The 2022 Plan allows the Company to make equity-based and cash-based incentive awards to its officers, employees, directors, and consultants and provides for the grant of incentive stock options, non-qualified stock options, stock appreciation rights, restricted stock awards, RSUs, and other stock-based awards. In addition, the number of shares reserved and available for issuance under the 2022 Plan shall automatically increase beginning on January 1, 2023 and each January 1 thereafter, byfive percent of the aggregate number of shares of common stock of all classes issued and outstanding on the immediately preceding December 31 or such lesser number of shares of common stock as determined by the compensation committee. As of December 31, 2025, there were 1,834,615 shares reserved for future issuance under the 2022 Plan.
In October 2022, the Board adopted, and in November 2022 its stockholders approved, the 2022 ESPP, which became effective immediately prior to and contingent upon the execution of the underwriting agreement related to the Company’s IPO. The number of shares of common stock that may be issued under the 2022 ESPP shall cumulatively increase beginning on January 1, 2023 and each January 1 thereafter through January 1, 2032, byone percent of the outstanding number of shares of common stock on the immediately preceding December 31 or such lesser number of shares as determined by the compensation committee. No shares of the Company's common stock have been issued. As of December 31, 2025, there were 971,743 shares reserved for future issuance under the 2022 ESPP.
In June 2023, the Board adopted the Inducement Plan to facilitate the granting of equity awards as an inducement material to new employees joining the Company. In April 2025, the Board amended the Inducement Plan to reserve an additional 500,000 authorized and unissued shares of common stock. The only persons eligible to receive awards under the Inducement Plan are individuals who are new employees and satisfy the standards for inducement grants under Nasdaq Listing Rule 5635(c)(4) or 5635(c)(3), as applicable. The terms of the Inducement Plan are identical to the terms of the 2022 Plan, except that no incentive stock options shall be awarded under the Inducement Plan. As of December 31, 2025, there were 613,976 shares reserved for future issuance under the Inducement Plan.
Stock Options
The Company has granted stock options with service-based vesting conditions. Stock options typically vest over four years and have a maximum term often years. The Company typically grants stock options to employees and non-employees at exercise prices deemed by the Board to be equal to the fair value of the common stock at the time of grant.
The assumptions that the Company used in the Black-Scholes option-pricing model to determine the grant date fair value of stock options granted during the years ended December 31, 2025 and 2024 were as follows:
| December 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Risk-free interest rate range | 3.71% - 4.37% | 3.76% - 4.57% |
| Dividend yield | 0.00% | 0.00% |
| Expected life of options (years) | 5.5 - 6.1 | 5.5 - 6.1 |
| Volatility rate range | 87.51% - 100.98% | 81.06% - 89.65% |
The following table summarizes the Company’s stock option activity during the year ended December 31, 2025:
| Numberof Shares | Weighted-AverageExercise Price | Weighted-AverageRemainingContractual Term(in years) | Aggregate IntrinsicValue(in thousands) | |
|---|---|---|---|---|
| Outstanding as of December 31, 2024 | 4,485,546 | $6.73 | 8.00 | $5,646 |
| Granted | 2,506,503 | 4.64 | ||
| Exercised | (225) | 3.89 | ||
| Forfeited or canceled | (815,683) | 5.78 | ||
| Outstanding as of December 31, 2025 | 6,176,141 | $6.01 | 7.72 | $1,051 |
| Vested and expected to vest as of December 31, 2025 | 6,176,141 | $6.01 | 7.72 | $1,051 |
| Vested and exercisable as of December 31, 2025 | 2,948,722 | $6.59 | 6.54 | $701 |
The aggregate intrinsic value of options is calculated as the difference between the exercise price of the stock options and the fair value of the Company’s common stock for those stock options that had exercise prices lower than the fair value of the common stock as of the end of the reporting period. The aggregate intrinsic value of options exercised during the years ended December 31, 2025 and 2024 was immaterial and $0.1 million, respectively.
The weighted-average grant date fair value of the Company’s stock options granted during the years ended December 31, 2025 and 2024 was $3.57 and $4.25 per option, respectively. As of December 31, 2025, there was $11.4 million of unrecognized stock-based compensation expense related to stock option grants. The Company expects to recognize this amount over a weighted-average period of 2.6 years.
RSUs
The Company has granted RSUs with service vesting based conditions. Unvested shares of restricted common stock may not be sold or transferred by the holder. They are legally issued and outstanding. These restrictions lapse according to the time-based vesting of each award.
The following table summarizes the Company’s RSU activity during the year ended December 31, 2025:
| Restricted Stock Units | Weighted-AverageGrant Date Fair Value | |
|---|---|---|
| Unvested at December 31, 2024 | 975,550 | $12.06 |
| Vested | (736,397) | 12.18 |
| Forfeited | (16,901) | 12.33 |
| Unvested at December 31, 2025 | 222,252 | $11.64 |
RSUs typically vest over four years. If and when an RSU vests, the Company will issueone share of common stock for each whole RSU that has vested, subject to satisfaction of the employee's tax withholding obligations. Upon vesting and settlement of RSUs, the Company may withhold the portion of those shares with a fair market value equal to the amount of the minimum statutory withholding taxes due. The withheld shares are accounted for as repurchases of common stock.
No RSUs were granted during the years ended December 31, 2025 and 2024. As of December 31, 2025, there was $2.2 million of unrecognized stock-based compensation expense related to RSUs. The Company expects to recognize this amount over a weighted-average period of 0.8 years.
The total fair value of RSUs vested during the years ended December 31, 2025 and 2024 was $9.0 million and $9.5 million, respectively.
Stock-Based Compensation Expense
Stock-based compensation expense included in the Company’s consolidated statements of operations and comprehensive loss for the years ended December 31, 2025 and 2024 is as follows (in thousands):
| Year Ended December 31, | ||
|---|---|---|
| 2025 | 2024 | |
| General and administrative | $10,732 | $11,206 |
| Research and development | 3,988 | 3,082 |
| Total stock-based compensation expense | $14,720 | $14,288 |
- Income Taxes
The Company adopted ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures effective January 1, 2025, on a prospective basis. The disclosures required by the standard are included below for the year ended December 31, 2025. Comparative prior-period disclosures have not been revised.
The components of loss before income taxes were as follows (in thousands):
| Year Ended December 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Domestic | $(78,014) | $(80,697) |
| Foreign | 189 | 253 |
| Total loss before income taxes | $(77,825) | $(80,444) |
The Company has had immaterial tax expense due to operating losses incurred since inception and no deferred tax provision in the current period.
The following table reconciles the U.S. federal statutory income tax rate to the Company’s effective income tax rate for the year ended December 31, 2025 (in thousands):
| Amount | Percentage | |
|---|---|---|
| Federal statutory income tax rate | $(16,344) | 21.0% |
| State and local income taxes, net of federal income tax effect | (16) | 0.0% |
| Foreign tax effects: | ||
| Other foreign jurisdictions | (39) | 0.0% |
| Tax credits: | ||
| Research and development tax credits | (2,692) | 3.5% |
| Changes in valuation allowances | 16,243 | (20.9%) |
| Nontaxable or nondeductible items: | ||
| Excess tax benefits on stock-based payments | 2,054 | (2.6%) |
| Stock Compensation | 769 | (1.0%) |
| Other | 25 | 0.0% |
| Effective income tax rate | $— | 0.0% |
As previously disclosed for the years ended December 31, 2024 and 2023, prior to the adoption of ASU 2023-09, the effective income tax rate differed from the federal statutory income tax rate as follows:
| Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Federal statutory income tax rate | 21.0% | 21.0% |
| State income taxes, net of federal benefit | 7.2% | 6.0% |
| Federal and state research and development tax credits | 6.0% | 4.4% |
| Stock-based compensation | (1.0%) | (1.3%) |
| Disallowed Expenditures | (2.2%) | (1.7%) |
| Change in deferred tax asset valuation allowance | (31.1%) | (28.5%) |
| Effective income tax rate | (0.1%) | (0.1%) |
The Company’s effective income tax rates for the years ended December 31, 2025, 2024, and 2023 were due primarily to state income tax resulting from interest income.
Deferred income taxes reflect the net tax effects of temporary differences between the carrying amount of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. The significant components of the Company’s net deferred income taxes were as follows (in thousands):
| Year Ended December 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Deferred Tax Assets | ||
| Net operating loss carryforward | $42,190 | $15,668 |
| Research and experimental expenditures | 16,600 | 25,763 |
| Tax credits | 13,394 | 9,991 |
| Capitalized Licenses | 2,967 | 3,259 |
| Accrued expenses and other current liabilities | 1,258 | 1,411 |
| Operating lease liabilities | 678 | 904 |
| Other | 1,237 | 926 |
| 78,324 | 57,922 | |
| Valuation allowance | (77,225) | (56,650) |
| Deferred tax asset | 1,099 | 1,272 |
| Deferred Tax Liabilities | ||
| Operating lease right-of-use assets | (623) | (864) |
| Depreciation | (476) | (408) |
| Deferred tax liability | (1,099) | (1,272) |
| Net deferred tax asset | $— | $— |
The Company's income tax provision for the year ended December 31, 2025 related to state income taxes. The Company has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets. Based on this, the Company has provided a valuation allowance for the full amount of the net deferred tax assets as the realization of the deferred tax assets is not determined to be more likely than not. During the year ended December 31, 2025, the valuation allowance increased by $20.6 million primarily due to the increase in the Company’s net operating loss, capitalized expenditures and tax credit carryforwards during the period.
As of December 31, 2025, the Company had $153.2 million and 156.4 million of federal and state net operating loss carryforwards (“NOLs”), respectively. Substantially all of the federal NOLs are not subject to expiration and the state NOLs begin to expire in 2038. These loss carryforwards are available to reduce future federal and state taxable income, if any. As of December 31, 2025, the Company also had federal and state research and development tax credit carryforwards of $10.6 million and $2.8 million respectively, to offset future income taxes, which will begin to expire in December 2035. These loss carryforwards are subject to review and possible adjustment by the appropriate taxing authorities.
Utilization of the Company’s NOL carryforwards and research and development credit carryforwards may be subject to a substantial annual limitation due to ownership change limitations that have occurred previously or that could occur in the future in accordance with Section 382 as well as similar state provisions. These ownership changes may limit the amount of NOL and research and development credit carryforwards that can be utilized annually to offset future taxable income and taxes, respectively. In general, an ownership change as defined by Section 382 results from transactions increasing the ownership of certain stockholders or public groups in the stock of a corporation by more than 50%over a three-year period. Since its formation, the Company has raised capital through the issuance of capital stock on several occasions. These financings could result in a change of control as defined by Section
- The Company has not yet conducted an analysis under Section 382 to determine if historical changes in ownership through December 31, 2025, would limit or otherwise restrict its ability to utilize its NOL and research and development credit carryforwards. In addition, future changes in ownership occurring after December 31, 2025 could affect the limitation in future years, and any limitation may result in expiration of a portion of the NOL or research and development credit carryforwards before utilization.
On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was signed into law. Among other provisions, this act includes permanently extended and modified certain expiring provisions of the 2017 Tax Cuts and Jobs Act and restored the immediate expensing of domestic research and development expenses. The Company has evaluated the impacts of these provisions and has concluded the OBBBA does not have a material impact on its consolidated financial statements other than reclassifications of the deferred tax assets.
The Company follows the provisions of ASC Topic 740-10, Accounting for Uncertainty in Income Taxes, which specifies how tax benefits for uncertain tax positions are to be recognized, measured, and recorded in financial statements; requires certain disclosures of uncertain tax matters; specifies how reserves for uncertain tax positions should be classified on the consolidated balance sheets; and provides transition and interim period guidance, among other provisions. As of December 31, 2025 and 2024, the Company hasnot recorded any amounts for uncertain tax positions. The Company’s policy is to recognize interest and penalties accrued on any uncertain tax positions as a component of income tax expense, if any, in its consolidated statements of operations and comprehensive loss. As of December 31, 2025 and 2024, the Company hadno reserves for uncertain tax positions. For the years ended December 31, 2025, 2024, and 2023, no estimated interest or penalties were recognized on uncertain tax positions.
The Company files federal income tax returns in the United States and Sweden and state income tax returns in Massachusetts and various other state jurisdictions. The Company’s tax returns for the years ended December 31, 2022 to December 31, 2025 remain open and subject to examination by the Internal Revenue Service and state taxing authorities.
- Net Loss Per Share
Basic and diluted net loss per share attributable to common stockholders for the years ended December 31, 2025, and 2024 was calculated as follows (in thousands, except share and per share amounts):
| December 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Numerator: | ||
| Net loss attributable to common stockholders—basic and diluted | $(77,905) | $(80,556) |
| Denominator: | ||
| Weighted-average common stock outstanding—basic and diluted | 38,509,281 | 33,791,817 |
| Net loss per share—basic and diluted | $(2.02) | $(2.38) |
As described in Note 8, the Pre-Funded Warrants to purchase up to an aggregate of 7,060,000 shares of the Company’s common stock at a purchase price of $8.499 per Pre-Funded Warrant were classified as a component of permanent equity in the Company's consolidated balance sheet as they are freestanding financial instruments that are immediately exercisable, do not embody an obligation for the Company to repurchase its own shares and permit the holders to receive a fixed number of shares of common stock upon exercise. All of the shares underlying the Pre-Funded Warrants have been included in the weighted-average number of shares of common stock used to calculate basic and diluted net loss per common share for the years ended December 31, 2025 and 2024, because the shares may be issued for little or no consideration, are fully vested, and are exercisable after the original issuance date of the Pre-Funded Warrants.
The Company’s potentially dilutive securities, which include stock options and RSUs, have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted-average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same. The Company excluded the following shares from the computation of diluted net loss per share attributable to common stockholders as of December 31, 2025 and 2024 because including them would have had an anti-dilutive effect:
| December 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Options to purchase common stock | 6,176,141 | 4,485,546 |
| Unvested restricted stock units | 222,252 | 975,550 |
- Segment Information
The Company manages its operations as asingle operating and reportable segment focused on the research and development of precision oncology therapies. The accounting policies of the single reportable segment are identical to those described in Note 2. The chief operating decision maker, who manages the Company’s operations on a consolidated basis, assesses performance for the reportable segment using consolidated net loss to monitor budget versus actual results and to determine how to effectively allocate the Company’s resources. The measure of segment assets is reported on the consolidated balance sheets as total consolidated assets.
The following table presents certain financial data including significant segment expenses for the Company’s reportable segment for the years ended December 31, 2025 and 2024 (in thousands):
| Year Ended December 31, | ||
|---|---|---|
| 2025 | 2024 | |
| ACR-368 direct research and development expenses | $23,035 | $34,135 |
| ACR-2316 direct research and development expenses1 | 7,523 | 3,384 |
| Other drug discovery programs direct research and development expenses | 2,294 | 4,037 |
| Personnel related indirect research and development expenses | 21,816 | 18,184 |
| Facilities, supplies and other indirect research and development expenses | 5,322 | 4,252 |
| General and administrative expenses | 24,124 | 25,207 |
| Other segment items2 | (6,209) | (8,643) |
| Net loss | $(77,905) | $(80,556) |
1 ACR-2316 direct research and development expenses include costs related to the Company’s novel, internally-discovered second clinical-stage asset, which was promoted to a development program upon being granted IND clearance in the third quarter of 2024 and includes clinical trial and related activities. Prior to IND clearance, costs related to preclinical drug discovery activities progression related to ACR-2316 were included in other drug discovery programs direct research and development expenses.
2 Other segment items consist of interest income and other income (expense), net. Interest income consists of interest income earned on cash equivalents and investments and amortization of premiums and accretion of discounts to maturity for available-for-sale debt securities. Other income (expense), net primarily consists of realized and unrealized gains and losses on foreign currency transactions, state taxes, and investment management fees.
- Commitments and Contingencies
Leases
The Company’s commitments under its operating leases are described in Note 7.
License Agreement
In January 2021, the Company entered into a license agreement and stock issuance agreement with Lilly (collectively, the “Lilly Agreement”), pursuant to which the Company has been granted an exclusive, royalty-bearing sublicensable license to certain patents owned or controlled by Lilly, with world-wide rights to commercially develop, manufacture, use, distribute and sell therapeutic products containing the compound prexasertib. The license from Lilly comprises three families of patent filings all relating to ACR-368. Additionally, pursuant to the Lilly Agreement, the Company received ACR-368 drug substance and drug product to be used in future research. In July 2025, the Company obtained unencumbered world-wide exclusive rights to freely engage in strategic partnerships, business development, and co-development opportunities for ACR-368, inclusive of all related intellectual property, in all territories and regions, after the triggering of Lilly’s limited right of first negotiation (“ROFN”), which the parties agreed under the terms of the agreement had expired.
As initial consideration for the license, the Company made a one-time, non-creditable, non-refundable upfront payment of $5.0 million. As additional consideration for the license, the Company is required to pay Lilly aggregate development and commercial milestone payments of up to $168.0 million, of which $5.0 million is due prior to a new drug application.
The Company is also obligated to pay a tiered percentage royalty on annual net sales ranging from single-digit up to a maximum of 10%, subject to certain specified reductions. Royalties are payable by the Company on a licensed product-by-licensed product and country-by-country basis until the later of the expiration of the last valid claim covering the licensed product in such country, expiration of all applicable regulatory exclusivities in such country for such licensed product and the tenth anniversary of the first commercial sale ofsuch licensed product in such country, provided, that the Company’s obligation to pay royalties for a given licensed product in a given country will expire earlier upon achievement of certain sales thresholds by generic products in such country.
As of December 31, 2025, no milestone payments or royalties have been incurred related to the Lilly Agreement.
In June 2022, the Company entered into a companion diagnostic agreement (the “Akoya Agreement”) with Akoya Biosciences, Inc., a wholly-owned subsidiary of Quanterix Corporation (“Akoya”), pursuant to which the Company has engaged Akoya to co-develop, validate, and commercialize the Company’s proprietary ACR-368 OncoSignature test, the companion diagnostic that will be used to identify patients with cancer most likely to respond to ACR-368. Subject to the terms of the Akoya Agreement, as subsequently amended, the Company paid Akoya a one-time, non-refundable, non-creditable upfront payment in the amount of $0.6 million. The Company is obligated to pay Akoya up to an aggregate of $20.3 million upon the achievement of specified development and pre-commercialization milestones. Through December 31, 2025, the Company has made aggregate payments of $18.2 million to Akoya. During the years ended December 31, 2025 and 2024, the Company recorded $1.2 million and $8.8 million, respectively, of research and development expense related to the achievement of milestones.
Indemnification Agreements
In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with each of its directors and executive officers that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or services as directors or executive officers. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited. To date, the Company has not incurred any material costs as a result of such indemnifications. The Company is not currently aware of any indemnification claims and has not accrued any liabilities related to such obligations in its consolidated financial statements as of December 31, 2025 and 2024.
Legal Proceedings
From time to time, in the ordinary course of business, the Company is subject to litigation and regulatory examinations as well as information gathering requests, inquiries and investigations. The Company is not currently party to any material legal proceedings and is not aware of any pending or threatened legal proceedings that could have an adverse effect on the Company's business, operating results or financial condition.
Other Contracts
The Company enters into contracts in the normal course of business with various third parties for preclinical research studies, clinical trials, testing, manufacturing and other services. These contracts generally provide for termination upon notice and are cancelable without significant penalty or payment, and do not contain any minimum purchase commitments.
- Employee Benefit Plans
Effective January 1, 2019, the Company adopted a 401(k) Plan for its employees, which is designed to be qualified under Section 401(k) of the Internal Revenue Code. Eligible employees are permitted to contribute to the 401(k) Plan within statutory and 401(k) Plan limits. The 401(k) Plan allows for the discretionary matching by the Company of a percentage of contributions. The Company contributed $0.3 million to the 401(k) Plan during the year ended December 31, 2025. The Company didnot make any contributions to the 401(k) Plan during the year ended December 31, 2024.
- Subsequent Events
Exercise of Pre-Funded Warrants
In January and February 2026, all Pre-Funded Warrants to purchase 7,060,000 shares of the Company's common stock were exercised via cashless exercise. Each Pre-Funded Warrant had an exercise price of $0.001 per share. Following the cashless exercise, no Pre-Funded Warrants remained outstanding.
Termination of Akoya Agreement
In February 2026, the Company and Akoya entered into a Termination and Transition Agreement (the “Termination”) pursuant to which they have mutually agreed to terminate the Akoya Agreement. The Termination does not involve any financial payments from or to any of the parties to such agreement.
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